Qualiculture

Our Projects

Technical and Quality Due Diligence

PRE – DD DOCUMENTATION

Confidentiality Agreement
Terms and Conditions

SCOPE OF WORK (SOW)

Analysis of the ‘Client Operations’- products, processes, markets and volumes
Defining the SOW considering the applicable regulations. Mainly Covers:
  1. Production and Process Controls
  2. Facility, Equipment and Utilities
  3. Laboratory Controls
  4. Material Controls
  5. Quality Management System
  6. Management Controls

SUBJECT MATTER EXPERTS

Manufacturing and Quality Control
Quality, Compliance and Regulatory Affairs

EXECUTION

Assessment of processes and products – Documents, Shop-floor visit, Personnel Interactions etc.
Quality and Compliance risk determination
Use of Conventional and Forensic Assessment Tools
Risk based sampling of documents for review
Preparation of Detailed Report and Executive Summary

DOCUMENTATION

Areas Covered and Findings
Risk Rating
Recommendations on Interventions (Personnel, Infrastructure, Quality etc.)
Proposal of Remedial Actions (Interim and Long Term)
Extended Business Opportunities (Addition of Markets)
Timelines for achieving the desired objectives etc.

PRE – EXECUTION ACTIVITIES

Request for apex documents for review – SMF, QM and VMP

Uploading of Documents in secure online database

Review of apex documents to prepare the SMEs on approach of assessment

Prepare the list of document for review during onsite visit and communication